FDA.reportPublic FDA data

Application 077248

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDETABLET;ORAL7.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-5911Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5911Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5922Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5922Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDEImpax GenericsANDACurrent
0115-5922Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
21695-601Pilocarpine HydrochloridePilocarpine HydrochlorideRebel Distributors CorpANDACurrent
60219-5922Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent